Clinical Trial: A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).

Detailed Summary: By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.
Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Current Primary Outcome:

• time to onset [ Time Frame: 10 days ]
  Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
• time of body temperature going back to normal [ Time Frame: 10 days ]
  Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• time of symptom disappearance [ Time Frame: 10 days ]
  Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
• case severity rate [ Time Frame: 10 days ]
  Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
• time of tetter and oral ulcer disappearance [ Time Frame: 10 days ]
  Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, etc.
• direct medical cost [ Time Frame: 10 days ]
  Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
• safety outcome [ Time Frame: 10 days ]
  Calculated by adverse event.

Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Dates:
Date Received: August 16, 2010
Date Started: May 2010
Date Completion:
Last Updated: July 20, 2012
Last Verified: July 2012